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| Name | Class |
|---|---|
| Virginia Commonwealth University | OTHER |
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The proposed research is a longitudinal human lab study to examine how measures of abuse liability and product appeal vary by e-cigarette device type, and how these lab assessments may predict subsequent e-cigarette and other tobacco use behavior at 1,3, and 6 months. An additional aim is to evaluate e-cigarette safety and tolerability among smokers by device type.
The proposed research is a longitudinal human lab study to involving 6 lab visits and 3 follow-up surveys at 1, 3, and 6 months after participants' last lab visit. Investigators will enroll 30 smokers (≥10 cig/day) who have not used e-cigarettes in the past 30 days and have never used e-cigarettes "fairly regularly." After a telephone screening to confirm eligibility, participants will attend Virginia Commonwealth University's (VCU) Clinical Behavioral Pharmacology Laboratory for all lab visits. The specific aims are to:
Aim 1. Examine how measures of abuse liability and product appeal vary by ECIG device type (Markten vs. e-Go).
Aim 2. Compare differences in abuse liability and product appeal between participants' usual brand of tobacco cigarette, Markten, and e-Go.
Aim 3. As an exploratory aim, examine the extent to which measures of abuse liability and product appeal as measured in the lab (including TPPT) predict participants' real-world ECIG use at the 1-, 3-, and 6-month follow-up surveys.
Aim 4. To monitor safety and tolerability the MarkTen and e-Go among smokers.
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| MarkTen and e-Go e-cigarettes | Device |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood nicotine concentration | A phlebotomist will draw 7mL of blood via venipuncture (no catheter) before and after directed tobacco product use at Lab Visits 2-6. | 3 weeks - before and after product administration |
| Nicotine withdrawal symptom alleviation | Participants will answer questions about their nicotine withdrawal symptoms (e.g. headache, tired, etc) | 3 weeks - before and after product administration |
| Change in subjective tobacco product appeal | Participants will answer questions about the positive and negative physical effects of using the product and how much they like the product. | 3 weeks - before and after product administration |
| Change in heart rate | Participants' heart rate (HR) will be monitored continuously during Lab Visits 2-6. Participants will commence physiological data measurement 30 minutes before the start of the directed tobacco use bout to establish a resting HR. | 3 weeks - before and after product administration |
| Number of Participants with Adverse Events by ECIG Device Type as a Measure of Safety and Tolerability | A count of the number of participants who report adverse events associated with the study, such as headache, chest pain, cough/sputum, nausea/vomiting, dizziness, confusion/stupor, feeling sick, sore throat, shortness of breath, abdominal pain, pleurisy, blurry vision, and tiredness, by e-cigarette device type. | 3 weeks - before and after product administration |
| Change in blood pressure | Participants' blood pressure (BP) will be monitored continuously during Lab Visits 2-6. Participants will commence physiological data measurement 30 minutes before the start of the directed tobacco use bout to establish resting BP. |
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Inclusion Criteria:
Exclusion Criteria:
Individuals fitting any of the following criteria will not be eligible to participate.
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A total of 30 community volunteers who currently use 10 or more cigarettes per day and have no immediate plans to quit smoking will be enrolled. Investigators will attempt to recruit an equal number of men and women of diverse racial/ethnic backgrounds. This preliminary study is not intended to address gender or race/ethnic differences.
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| Name | Affiliation | Role |
|---|---|---|
| Jennifer Pearson, PhD | Truth Initiative | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| American Legacy Foundation | Washington D.C. | District of Columbia | 20001 | United States | ||
| Virginia Commonwealth University |
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| ID | Term |
|---|---|
| D014029 | Tobacco Use Disorder |
| ID | Term |
|---|---|
| D019966 | Substance-Related Disorders |
| D064419 | Chemically-Induced Disorders |
| D001523 | Mental Disorders |
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Plasma nicotine: Investigators will examine change in plasma nicotine concentration before and after 5 minutes of directed product use (10 total puffs). At the start of the session, a phlebotomist will draw 7mL of blood via venipuncture (no catheter). Participants will then be directed to take a puff of their own brand/assigned e-cigarette device every 30 seconds for 5 minutes. At the end of the directed use session, the phlebotomist will draw another 7mL of blood via venipuncture. Blood samples will be processed at the Center for Study of Tobacco Products lab, frozen, and walked across the street to the Bioanalytical Mass Spectrometry Core Laboratory at VCU for cotinine/3-OH analysis using previously developed assays. Blood samples will not be retained for additional analyses.
| 3 weeks - before and after product administration |
| Richmond |
| Virginia |
| 23284 |
| United States |